#1 Clinical Trials Search in Europe

Eribulin

Eribulin, also known by its brand name Halaven, is a chemotherapy drug being studied in various clinical trials for the treatment of advanced solid tumors and metastatic cancers. These trials aim to evaluate the safety, efficacy, and optimal dosing of eribulin in different patient populations, including those with impaired liver or kidney function. Researchers are exploring eribulin’s potential as both a first-line treatment and in patients who have progressed on other therapies.

Table of Contents

What is Eribulin?

Eribulin, also known by its brand names Halaven or E7389, is a chemotherapy medication used primarily in the treatment of certain types of cancer[1]. It belongs to a class of drugs called microtubule inhibitors, which work by interfering with the growth and spread of cancer cells in the body.

What Conditions Does Eribulin Treat?

Eribulin is primarily used to treat:

  • Metastatic Breast Cancer: This is breast cancer that has spread to other parts of the body. Eribulin is often used when other treatments have not been effective[1][2].
  • Advanced Solid Tumors: In some cases, Eribulin may be used to treat other types of advanced or metastatic solid tumors that are no longer responding to available therapies[5].

How is Eribulin Administered?

Eribulin is typically administered as follows:

  • It is given as an intravenous (IV) injection, which means it’s delivered directly into your bloodstream through a vein[1].
  • The usual dosing schedule is on days 1 and 8 of a 21-day cycle. This means you receive the medication on the first and eighth day, then have a break for the rest of the three-week period[1][5].
  • The standard dose is 1.4 mg/m² (milligrams per square meter of body surface area), but this can vary depending on your specific situation[2].

Side Effects and Safety

Like all medications, Eribulin can cause side effects. Some of the most common ones include[1]:

  • Asthenia/Fatigue: Feeling of weakness or lack of energy
  • Neutropenia: A decrease in white blood cells, which can increase the risk of infections
  • Alopecia: Hair loss
  • Nausea: Feeling of sickness in the stomach
  • Peripheral Neuropathy: Numbness, tingling, or pain in the hands and feet
  • Constipation: Difficulty in bowel movements

Your healthcare team will monitor you closely for these and other potential side effects throughout your treatment[1].

Special Considerations

There are some special considerations when using Eribulin:

  • Liver Function: If you have liver problems, your doctor may adjust your dose of Eribulin. The medication is processed differently in people with mild, moderate, or severe liver impairment[4].
  • Kidney Function: Similarly, if you have kidney problems, your doctor will consider this when determining your Eribulin dose. The medication’s behavior in the body can be affected by moderate or severe kidney impairment[5].
  • Pregnancy and Breastfeeding: Eribulin can harm an unborn baby, so it’s important to use effective birth control during treatment. It’s also not known if Eribulin passes into breast milk, so breastfeeding is not recommended during treatment.

Ongoing Research

Researchers continue to study Eribulin to understand more about its effects and potential uses. Some areas of ongoing research include:

  • Combination Therapies: Studies are looking at combining Eribulin with other medications, such as bevacizumab, for treating metastatic breast cancer[2].
  • First-line Treatment: While Eribulin is often used after other treatments have failed, some studies are exploring its use as a first-line treatment for metastatic breast cancer[6].
  • Scalp Cooling: Research is being conducted to see if scalp cooling techniques can help prevent hair loss in patients receiving Eribulin and other chemotherapy drugs[3].

Remember, while this information provides a general overview, your healthcare team is the best source of information about how Eribulin relates to your specific situation. Always consult with them about any questions or concerns you may have about your treatment.

Aspect Details
Drug Name Eribulin (also known as E7389, Halaven)
Type of Drug Chemotherapy, microtubule dynamics inhibitor
Administration Intravenous injection, typically on days 1 and 8 of a 21-day cycle
Cancers Studied Advanced solid tumors, metastatic breast cancer, HER2-negative breast cancer
Key Study Objectives Efficacy, safety, pharmacokinetics, optimal dosing
Special Populations Patients with liver impairment, kidney impairment, elderly patients
Outcome Measures Tumor response, time to progression, overall survival, adverse events
Dosage Range 0.7 mg/m² to 1.4 mg/m², adjusted based on organ function and tolerability

FAQ

  • What is eribulin and how does it work? Eribulin is a chemotherapy drug derived from a sea sponge compound. It works by inhibiting cell division and growth of cancer cells by interfering with the microtubule dynamics in cells.
  • What types of cancer is eribulin being studied for? Eribulin is being studied for various advanced solid tumors and metastatic cancers, including breast cancer. Clinical trials are evaluating its use in patients with different stages of disease and treatment histories.
  • How is eribulin administered? Eribulin is typically given as an intravenous (IV) injection. In most trials, it is administered on days 1 and 8 of a 21-day cycle, though exact dosing may vary based on the study and patient factors.
  • What are some of the side effects being monitored in eribulin trials? Common side effects being monitored include neuropathy (nerve damage), changes in blood cell counts, liver function abnormalities, and other adverse events. Trials are assessing the overall safety profile and tolerability of eribulin.
  • How do researchers measure if eribulin is working in clinical trials? Researchers use various measures to assess eribulin's efficacy, including tumor response rates, time to disease progression, overall survival, and quality of life assessments. They also look at pharmacokinetics to understand how the drug moves through the body.

Ongoing Clinical Trials on Eribulin

  • Study of melphalan followed by eribulin, vinorelbine, or capecitabine versus eribulin, vinorelbine, or capecitabine alone for metastatic breast cancer patients with liver disease

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

  • A Study of Evorpacept Combined with Trastuzumab and Chemotherapy for Patients with Metastatic HER2-Positive Breast Cancer

    Recruiting

    1 1 1
    Investigated drugs:
    France Italy Spain

  • Study on the Effectiveness and Safety of INT230-6 (Vinblastine Sulfate, Cisplatin) for Adults with Metastatic Soft Tissue Sarcomas

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Spain

  • Study of ELVN-002 with Trastuzumab and Chemotherapy for Patients with Advanced HER2+ Solid Tumors, Colorectal Cancer, and Breast Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Italy The Netherlands Spain

  • Study of MEN1611 and Eribulin for Advanced Metaplastic Breast Cancer in Patients with PIK3CA/PTEN Alterations

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of Eribulin for Adults with Advanced Solitary Fibrous Tumor in Second or Third Line Treatment

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion. PK studies help determine optimal dosing.
  • Child-Pugh System: A scoring system used to assess the severity of liver disease and impairment. It helps determine appropriate dosing for patients with liver problems.
  • RECIST (Response Evaluation Criteria in Solid Tumors): A set of rules used to measure how well a cancer patient responds to treatment. It defines when tumors in cancer patients improve, stay the same, or worsen during treatment.
  • Open-label study: A type of clinical trial where both the researchers and participants know which treatment is being administered.
  • Metastatic cancer: Cancer that has spread from its original site to other parts of the body.
  • HER2-negative: Breast cancers that do not have excess HER2 protein. This affects which treatments may be most effective.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Objective response rate: The proportion of patients whose cancer shrinks or disappears after treatment.
  • Clinical benefit rate: The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, and stable disease to a therapeutic intervention in clinical trials.

References

  1. https://clinicaltrials.gov/study/NCT02864030
  2. https://clinicaltrials.gov/study/NCT01941407
  3. https://clinicaltrials.gov/study/NCT04986579
  4. https://clinicaltrials.gov/study/NCT00706095
  5. https://clinicaltrials.gov/study/NCT01418677
  6. https://clinicaltrials.gov/study/NCT02061085